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  6. Focus Area: Food Safety
  1. Focus Areas of Regulatory Science Report

Focus Area: Food Safety


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Importance to FDA

FDA faces unique challenges in the oversight of human and animal food safety. The source of these challenges involves factors that are driven, in part, by globalization, the increasing complexity of international supply chains of human and animal food and changing consumer demands. FDA oversees about 78 percent of the U.S. food supply, covering all foods (including imports and exports and human dietary supplements), except for meat, poultry, fish, and some egg products (FDA responsibilities include both imported and exported foods, which are regulated by USDA). This oversight involves continuous surveillance of the human and animal food supply for ongoing and emerging threats, development of methods for detecting and countering threats, and deployment of those methods to domestic and global partners. FDA prioritizes communicating results and activities related to food supply to ensure the safety of the public and their animals.


Below are some of the ways that FDA regulatory science research supports food safety:

  • Using WGS to investigate pathogen (bacteria, viruses and the parasite cyclospora cayetenensis) contamination of human foods and contamination of animal food that may have been potentially exposed and shared with humans. WGS is used to: (1) characterize selected pathogens; (2) provide linkages between food or environmental samples to human clinical illnesses, that might not be found with routine testing; and (3) provide the foundation for metagenomic methods as they are increasingly applied to identifying pathogens.
  • Evaluating dietary exposure to per- and polyfluoroalkyl substances (PFAS), as a result of environmental contamination of food. PFAS are human-made chemicals used in a variety of applications including in stain- and water-resistant fabrics and carpeting, cleaning products, paints, and fire-fighting foams. FDA researchers are at the forefront of developing new comprehensive and more sensitive testing methods to measure low levels of PFAS concentrations in food. The validated analytical methods have has been used to test a wide variety of foods in FDA’s Total Diet Study, targeted sampling of certain commodities such as seafood, as well as FDA- regulated products that are grown in areas with environmental PFAS contamination.
  • Investigating relationships between increased reports of dilated cardiomyopathy in dogs and the consumption of certain dog foods containing high amounts of ingredients such as peas, chickpeas, lentils, and specific types of potatoes.
  • Developing and validating methods to detect food contaminants and unapproved product irradiation in diagnostic samples from animals that consume pet food, and pet treat products, and pet treats. Testing diagnostic specimens provides insights into consumer complaint case investigations. Such investigations require validated methods for diagnostic samples from animals such as urine, blood, feces, saliva, liver, and kidney.
  • Enabling the expansion and validation of detection methods via multi-laboratory projects through the Veterinary Laboratory Investigation and Response Network (Vet-LIRN) program enables the expansion and validation of detection methods via multi-laboratory projects, thereby increasing the number of validated methods available to Vet-LIRN labs during outbreaks or other emergency events. The program also strengthens collaborations between network laboratories, which is crucial for providing a quick response in an emergency.
  • Substantially increasing sample throughput to improve detection of disallowed veterinary drug residues in honey intended for human consumption. We have done this by modifying the existing method of analysis, providing additional data and tools to the agency to inform regulatory analysis and policy.
  • Implementing a laboratory flexible funding model (LFFM) which offers funding to states to engage in different projects that have been prioritized by the agency. LFFM serves to leverage state capacity for high-priority agency projects, stimulates methodology and technology transfer with state partners, and provides FDA with an expanded network of labs that can collaborate to provide vigilance and monitoring on FDA regulated products.
  • Evaluating and approving the data and methods submitted by manufacturers who market rapid-screening tests for detecting antibiotic drugs in Grade A raw milk. Such rapid screening is imperative to ensure safety of the US milk supply because this perishable commodity needs to be tested on the spot.
  • Developing and validating a high-resolution mass spectrometric method for the quantitation and confirmation of multiple veterinary drug residues in raw milk. This supports regulatory decision-making on veterinary drug residues in raw milk to help keep the nation’s milk supply safe for human consumption.
  • Developing and validating xMAP® food allergen detection assay (xMAP FADA) to overcome the limitation of the commonly used ELISA as a regulatory method for allergen detection. It is a multiplex immunoassay that allows detection of many different food allergens simultaneously, currently 14 allergens plus gluten, and continues to be expanded to more allergens, such as sesame.
  • Developing chemical methods such as rapid screening for honey for adulterants, detection of foreign oils in olive oil, and authentication of extra virgin olive oil. Economically motivated adulteration (EMA) is not just an economic issue as food fraud but can lead to health issues and even death, such as in the case of melamine (2008). To fight the everchanging ways fraud is committed, FDA researchers must be creative and proactive in developing methods to detect possible adulterations.
  • Developing DNA barcoding to ensure consumers receive the fish they purchased.




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